Tuesday, August 18, 2009


BEIJING, Aug 19 — A Chinese pharmaceutical company has becomethe first in the world to produce a safe and effective vaccine for the H1N1 virus, according to its developer.

Studies showed the inoculation made by Beijing-based Sinovac Biotech met “international criteria for vaccines” and caused no severe adverse reactions in any of the 1,614 volunteers who received it, Sinovac said in an e-mail statement yesterday.

Researchers from China’s Centre for Disease Control and Prevention and the National Institute for the Control of Pharmaceutical and Biological Products conducted and supervised the test in Beijing.

“Trials show that the first dose of vaccine triggers an immune response in the human body, good enough to protect against the A/H1N1 virus strain,” Sinovac general manager Yin Weidong said.

But Sinovac did not give details about the efficacy of differing doses or vaccination methods used.

The results are the first reported anywhere in the world on a vaccine to fight the new H1N1 strain that has sparked the first influenza pandemic in 41 years, said Sinovac, which was formed in 2001 to make immunisations for hepatitis.

It is compiling data on the flu shot as soon as possible before seeking regulatory approval for it in China.

Sanofi-Aventis, GlaxoSmithKline and other vaccine makers are racing to prepare inoculations against the pandemic virus before the Northern Hemisphere winter.

Ten Chinese pharmaceutical companies have joined the global race to produce an effective vaccine, and more than 13,300 volunteers throughout China — including Health Minister Chen Zhu — are taking part in clinical trials.

“The reported results of the Sinovac trial of H1N1 vaccine hinting at good efficacy after a single inoculation are encouraging,” said Lorena Brown, professor of microbiology and immunology at the University of Melbourne.

“These will be of particular interest when the data are analysed in terms of age group, vaccine dose, vaccine form and the requirement for adjuvant, all of which can effect the practicality of vaccine manufacture and use.”

The World Health Organisation (WHO) said in an Aug 6 statement that data on the effectiveness of the first immunisations against the H1N1 virus will be limited when they are first administered.

Key information about the required composition of vaccines and whether one or two shots are needed probably will not be available until late next month, Marie-Paule Kieny, director of WHO’s initiative for vaccine research, said in a telephone interview from Washington yesterday. That data will help determine how many people could be immunised over the next few months, she said.

In June, Sinovac said that it received an initial order for four million doses from the Chinese government, and expects delivery by the end of next month. It anticipated additional orders in October, taking the total to 10 million doses.

Australia’s CSL, the Southern Hemisphere’s only flu vaccine maker, expects preliminary results on the first dose of its vaccine next week, said Rachel David, a company spokesman.

No severe adverse reactions have been observed so far, and the Melbourne-based company plans to submit the data to the Australian government on Sept 4, she said.

There have been at least 177,457 confirmed cases globally, including 1,462 deaths, according to the WHO’s latest statistics updated on Aug 6.

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